Pharmacomechanical ThrombolysisNCT05356767
The Study of Percutaneous Mechanical Thrombectomy Treating Acute Deep Vein Thrombosis of Lower Extremities
An observational study of Pharmacomechanical Thrombolysis and Deep Vein Thrombosis, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
Trial summary
This study is a prospective, multicenter, real world, observational study intended to understand tmechanical thrombectomy in the treatment of acute deep venous thrombosis of lower extremities, It is estimated that 600 patients with DVT were enrolled in the group at 24 centers nationwide from May 2022 to May2024. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pharmacomechanical Thrombolysis, Deep Vein Thrombosis
- What is being tested?
- Pharmacomechanical thrombolysis
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 1 Apr 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Deep vein thrombosis
Who may be able to join
- The symptoms of deep venous thrombosis of lower extremities occurred within 14 days (including 14 days)；
- Lower extremity deep venous thrombosis involving iliac vein or / and femoral vein ;
- Obtain the informed consent of all patients.
Who cannot join
- Patients with a previous history of ipsilateral proximal lower limb deep venous thrombosis ;
- patients who are prohibited from thrombolytic therapy;
- inferior vena cava compression syndrome；
- Allergic to heparin, low molecular weight heparin or contrast medium;
- Patients who have participated in clinical trials of other drugs or medical devices that interfere with this clinical trial in the past 3 months;
- Patients who do not want to participate in this trial;
- Patients with poor compliance, or those who the researchers think are not suitable for selection.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chunshuihe
Chengdu, Sichuan, 610000
Chunshui He, Doctor, 86-18981885601, chunshuihe@msn.com
Wei Huang, Master, 86-18008068144, 254652468@qq.com
About this study
Official title: the Director of Vascular Surgery of Hospital of Chengdu University of Traditional Chinese Medicine
This study is a prospective, multicenter, real world, observational study intended to understand tmechanical thrombectomy in the treatment of acute deep venous thrombosis of lower extremities, It is estimated that 600 patients with DVT were enrolled in the group at 24 centers nationwide from May 2022 to May2024. we can obtain data on the incidence of sequelae of deep venous thrombosis after PMT, and analyze the factors that may affect the efficacy of PMT.
Read the detailed description
Through inclusion and exclusion criteria, 600 patients were collected. This experiment was an observational study case series, and no control group was established. The patency of the lower extremity veins was assessed by lower extremity venous ultrasound or lower extremity venography. According to the postoperative symptoms and signs of the patients, the Villata score, (VEINS QoL)/Sym questionnaire and VCSS score were used to understand the PTS situation.Postoperative clinical follow-up was performed at 6 months, 12 months, 18 months, and 24 months. The main endpoints were the patency rate of lower extremity deep veins at 6 months after operation and the incidence of PTS (Villalta score) at 2 years after operation.
- Being tested
- Pharmacomechanical thrombolysis
- Keywords
- Pharmacomechanical thrombolysis, Deep vein thrombosis, post-thromboticsyndrome
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacomechanical thrombolysisProcedure or surgery
Pharmacomechanical thrombolysis
| Study group | Role | What they receive |
|---|---|---|
| post-thromboticsyndrome | suffering from PTS (Villalta score) at 2 years after operation. Receives: Procedure: Pharmacomechanical thrombolysis | |
| n-post-thromboticsyndrome | none of PTS (Villalta score) at 2 years after operation. Receives: Procedure: Pharmacomechanical thrombolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower extremity deep vein patency rate 6 months after operation
The patency of the lower extremity veins was assessed by lower extremity venous ultrasound or lower extremity venography.
Measured: 6 months
Incidence of sequelae of deep venous thrombosis after PMT
According to the postoperative symptoms and signs of the patients, the Villata score, (VEINS QoL)/Sym questionnaire and VCSS score were used to understand the PTS situation.
Measured: 24 months
Secondary outcomes (6)
Total duration of interventional treatment
Including the entire operation time of interventional surgery
Measured: 1 day
Total urokinase dosage
interventional surgery urokinase dosage
Measured: 1 day
Lower extremity deep venous patency rate of patients before discharge
The patency rate of lower extremity deep veins in patients 1 week after operation
Measured: 1 week
Postoperative quality of life score (QOL)
Postoperative quality of life scoring using the QOL scale
Measured: 6 months,12 months,18 months and 24 months
reoperation rate
Reoperation due to thrombosis, pts
Measured: 6 months,12 months,18 months and 24 months
Incidence of bleeding complications
Symptoms of perioperative hemorrhage
Measured: 1day，7day，3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 Apr 2022
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacomechanical ThrombolysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunshui He, Chengdu University of Traditional Chinese Medicine
- Investigators
- Meng Ye, doctor, Principal investigator, Study Principal Investigator RenJi HospitalZiheng Wu, doctor, Principal investigator, Study Principal Investigator Zhejiang UniversityLianrui Guo, doctor, Principal investigator, Study Principal Investigator Xuanwu Hospital, BeijingXin Fang, doctor, Principal investigator, Study Principal Investigator Hangzhou first people's Hospital of Medical College of Zhejiang UniversityHongfei Sang, doctor, Principal investigator, Study Principal Investigator Second Affiliated Hospital of Suzhou UniversityQiang Li, doctor, Principal investigator, Study Principal Investigator Qingdao Haici Hospital affiliated to Qingdao UniversityZibo Feng, doctor, Principal investigator, Study Principal Investigator Liyuan Hospital of Tongji Medical College, Huazhong University of Science and TechnologyZhenyu Shi, doctor, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356767
- Sponsor's protocol ID
- ChengduUTCMvs3
- Status last verified
- May 2022
- First submitted
- 27 Apr 2022
- Last updated
- 11 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Director of Vascular Surgery of Hospital of Chengdu University of Traditional Chinese Medicine
- ClinicalTrials.gov ID
- NCT05356767
- Acronym / sponsor ID
- ChengduUTCMvs3
- Keywords
- Pharmacomechanical thrombolysis, Deep vein thrombosis, post-thromboticsyndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, multicenter, real world, observational study intended to understand tmechanical thrombectomy in the treatment of acute deep venous thrombosis of lower extremities, It is estimated that 600 patients with DVT were enrolled in the group at 24 centers nationwide from May 2022 to May2024. we can obtain data on the incidence of sequelae of deep venous thrombosis after PMT, and analyze the factors that may affect the efficacy of PMT.
Detailed description
Through inclusion and exclusion criteria, 600 patients were collected. This experiment was an observational study case series, and no control group was established. The patency of the lower extremity veins was assessed by lower extremity venous ultrasound or lower extremity venography. According to the postoperative symptoms and signs of the patients, the Villata score, (VEINS QoL)/Sym questionnaire and VCSS score were used to understand the PTS situation.Postoperative clinical follow-up was performed at 6 months, 12 months, 18 months, and 24 months. The main endpoints were the patency rate of lower extremity deep veins at 6 months after operation and the incidence of PTS (Villalta score) at 2 years after operation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| post-thromboticsyndrome | – | Procedure: Pharmacomechanical thrombolysissuffering from PTS (Villalta score) at 2 years after operation. |
| n-post-thromboticsyndrome | – | Procedure: Pharmacomechanical thrombolysisnone of PTS (Villalta score) at 2 years after operation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Deep vein thrombosis
Key inclusion criteria (3 listed)
- The symptoms of deep venous thrombosis of lower extremities occurred within 14 days (including 14 days)；
- Lower extremity deep venous thrombosis involving iliac vein or / and femoral vein ;
- Obtain the informed consent of all patients.
Key exclusion criteria (7 listed)
- Patients with a previous history of ipsilateral proximal lower limb deep venous thrombosis ;
- patients who are prohibited from thrombolytic therapy;
- inferior vena cava compression syndrome；
- Allergic to heparin, low molecular weight heparin or contrast medium;
- Patients who have participated in clinical trials of other drugs or medical devices that interfere with this clinical trial in the past 3 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacomechanical thrombolysisPharmacomechanical thrombolysis | Procedure or surgery | n-post-thromboticsyndrome, post-thromboticsyndrome |
Primary outcome
Lower extremity deep vein patency rate 6 months after operation
Time frame: 6 months
The patency of the lower extremity veins was assessed by lower extremity venous ultrasound or lower extremity venography.
Incidence of sequelae of deep venous thrombosis after PMT
Time frame: 24 months
According to the postoperative symptoms and signs of the patients, the Villata score, (VEINS QoL)/Sym questionnaire and VCSS score were used to understand the PTS situation.
6 secondary outcomes
Total duration of interventional treatment
Time frame: 1 day
Total urokinase dosage
Time frame: 1 day
Lower extremity deep venous patency rate of patients before discharge
Time frame: 1 week
Postoperative quality of life score (QOL)
Time frame: 6 months,12 months,18 months and 24 months
reoperation rate
Time frame: 6 months,12 months,18 months and 24 months
Incidence of bleeding complications
Time frame: 1day，7day，3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meng Ye, doctor principal investigator
Study Principal Investigator RenJi Hospital
Ziheng Wu, doctor principal investigator
Study Principal Investigator Zhejiang University
Lianrui Guo, doctor principal investigator
Study Principal Investigator Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pharmacomechanical Thrombolysis and Deep Vein Thrombosis, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunshui He, doctor (86-18981885601 ext. 028-87766214, chunshuihe@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower extremity deep vein patency rate 6 months after operation (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.